AzTrials
AzTrials

Breast CancerPhase 2NCT02897050

Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer

A Phase 2 study testing Docetaxel, Capecitabine and Cyclophosphamide (tablet) in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial summary

This multi-center, open-label, phase II randomized controlled trial is to evaluate the efficacy of docetaxel(T) combined with metronomic cyclophosphamide/capecitabine (mCX) followed by fluorouracil /epirubicin/cyclophosphamide (FEC) versus T followed by FEC as neoadjuvant chemotherapy in treating women with triple… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Docetaxel, Capecitabine and Cyclophosphamide (tablet)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
4 sitesChina
Study dates
Sep 2016to Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patients signed the written informed consent
  • The patients present with non-metastatic unilateral invasive ER-negative (IHC<10%), PR-negative(IHC<10%), HER2-negative breast cancer with a primary breast tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging.
  • 18 years old< age < 70 years old.
  • The patients have no history of hormone therapy, chemotherapy, breast cancer surgery and radiotherapy.
  • The patients have normal cardiac functions by echocardiography.
  • The patients' ECOG scores are ≤2.
Show all 15Show fewer
  • The patients can swallow pills.
  • The results of patients' blood tests are as follows:
  • Hb≥90g/L;
  • WBC≥4E+9/L;
  • Plt≥100E+9/L;
  • Neutrophils≥1.5E+9/L;
  • ALT and AST ≤ triple of normal upper limit;
  • TBIL ≤ 1.5 times of normal upper limit;
  • Creatinine ≤ 1.5 times of normal upper limit.

Who cannot join

  • The patients have other cancers at the same time or have the history of other cancers except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus;
  • The patients have active infections that were not suitable for chemotherapy;
  • The patients have severe non-cancerous diseases.
  • The patients have bilateral breast cancers or male breast cancers or inflammatory breast cancers.
  • The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.
  • The patients are in some special conditions that they cannot understand the written informed consent, such as they are demented or hawkish.
  • The patients have allergic history or contraindication of any of the interventional drugs.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, 510120

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

  • Xinjiang Medical School Cancer Hospital

    Ürümqi, Xinjiang, 830000

Other trials in China

About this study

Official title: Phase II Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer

This multi-center, open-label, phase II randomized controlled trial is to evaluate the efficacy of docetaxel(T) combined with metronomic cyclophosphamide/capecitabine (mCX) followed by fluorouracil /epirubicin/cyclophosphamide (FEC) versus T followed by FEC as neoadjuvant chemotherapy in treating women with triple negative breast cancer (TNBC), and to study the anti-tumor immune effect of metronomic neoadjuvant chemotherapy. 186 stage M0 TNBC patients who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging are randomly enrolled to receive neoadjuvant T combined with mCX (3 cycles) followed by FEC (3 cycles) or T (3cycles) followed by FEC (3 cycles) before surgery. The primary end point is pathological complete response (pCR) rate, and the secondary end points include: clinical response rate, toxicities, breast-conserving rate, Ki67 and CD31 reduction rate, changes in the percentages of peripheral blood or tumor microenvironmental regulatory T cells (Treg), T helper cells (Th), CD8+ T cell, and tumor-specific CTL, and changes in tumor microenvironmental immune cytokines. Once there is a significant statistical difference in terms of pCR rate between two groups, 3-year disease-free survival (DFS) and 3-year overall survival (OS) will be included in the secondary end points. The aims of this study are to determine whether the neoadjuvant T combined with metronomic CX followed by FEC can significantly increase the pCR rate in TNBC with acceptable toxicity, and to explore the anti-tumor immune effect of metronomic neoadjuvant chemotherapy.

Conditions
Breast Cancer
Being tested
Docetaxel, Capecitabine, Cyclophosphamide (tablet), Fluorouracil, Epirubicin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Docetaxel 75mg/m2, iv, d1 or 100mg/m2, iv, d1

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine 1200mg/m2/d, po, d1-d21

  • Cyclophosphamide (tablet)Drug

    Also called CTX

    Cyclophosphamide 50 mg/d, po, d1-d21

  • FluorouracilDrug

    Also called 5-Fu

    Fluorouracil 500mg/m2, iv, d1

  • EpirubicinDrug

    Epirubicin 100mg/m2, iv, d1

  • Cyclophosphamide (injection)Drug

    Also called CTX

    Cyclophosphamide 500mg/m2, iv, d1

Study groups in NCT02897050
Study groupRoleWhat they receive
T+mCX followed by FECExperimentalDocetaxel 75mg/m2, iv, d1 + CTX 50 mg/d, po, d1-d21 + capecitabine 1200mg/m2/d, po, d1-d21 * 3 cycles (21 days per cycle) followed by fluorouracil 500mg/m2,iv,d1 + epirubicin 100mg/m2,iv,d1 + cyclophosphamide 500mg/m2,iv,d1 * 3 cycles (21 days per cycle)
Receives: Drug: Docetaxel; Drug: Capecitabine; Drug: Cyclophosphamide (tablet); Drug: Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide (injection)
T followed by FECActive comparatorDocetaxel 100mg/m2, iv, d1 * 3 cycles (21 days per cycle) followed by fluorouracil 500mg/m2,iv,d1 + epirubicin 100mg/m2,iv,d1 + cyclophosphamide 500mg/m2,iv,d1 * 3 cycles (21 days per cycle)
Receives: Drug: Docetaxel; Drug: Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide (injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response (pCR) rate

    Measured: at definitive surgery (20-24 weeks after the first dose of study medication)

Secondary outcomes (9)

  1. Ultrasound response rate

    Measured: at definitive surgery (20-24 weeks after the first dose of study medication)

  2. Breast-conserving surgery rate

    Measured: at definitive surgery (20-24 weeks after the first dose of study medication)

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: during on-neoadjuvant therapy period (defined as the period from the first dose of study medication up to 30 days of the last dose)

  4. Tumor Ki67 reduction rate in relation to neoadjuvant therapy

    Measured: at definitive surgery (20-24 weeks after the first dose of study medication)

  5. Tumor CD31 reduction rate in relation to neoadjuvant therapy

    Measured: at definitive surgery (20-24 weeks after the first dose of study medication)

  6. Peripheral blood CD8+ T cell percentage change in relation to neoadjuvant therapy

    Measured: at definitive surgery (20-24 weeks after the first dose of study medication)

  7. Peripheral blood regulatory T cell percentage change in relation to neoadjuvant therapy

    Measured: at definitive surgery (20-24 weeks after the first dose of study medication)

  8. Peripheral blood tumor specific T cell (CTL) percentage change in relation to neoadjuvant therapy

    Measured: at definitive surgery (20-24 weeks after the first dose of study medication)

  9. Peripheral blood T helper cell percentage change in relation to neoadjuvant therapy

    Measured: at definitive surgery (20-24 weeks after the first dose of study medication)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2022 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02897050
Sponsor's protocol ID
BCCT2016001
Status last verified
Apr 2022
First submitted
7 Sep 2016
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Capecitabine and Cyclophosphamide (tablet) in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate (time frame: at definitive surgery (20-24 weeks after the first dose of study medication)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02897050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in